FDA Clears Boston Scientific To Expand Indications For CRE™ Balloon To Include Into Stone Extraction

In short

In a press release issued by PR Newswire, Boston Scientific Corporation has announced the FDA clearance for an expanded use indication for the CRE™ Wireguided Balloon Dilator for endoscopic dilation of the Sphincter of Oddi following sphincterotomy.

Background

Boston Scientific says its CRE Wireguided Balloon Dilator is constructed of Pebax® to provide durability and flexibility, and is designed to gradually open strictures by delivering three distinct pressure-controlled diameters in a single balloon. The rounded-shoulder design of the balloon is engineered to help facilitate endoscopic visualisation or balloon endoscopy and provide greater usable balloon surface area during dilation.

Until now the indications for use have been limited to dilation of strictures) in the digestive tract. The new indication offers physicians the ability to now perform Dilation Assisted Stone Extraction (DASE) with the CRE Wireguided Balloon Dilator. This is an alternative method for the removal of difficult stones in the biliary duct.

Clinician comments

“Since becoming available, the DASE procedure with the CRE Wireguided Balloon has significantly changed my approach to the endoscopic removal of large common bile duct stones. It is an easy-to-use technique, and I have had great success in managing difficult stones,” said Kenneth Sigman, M.D., at Birmingham Gastroenterology Associates in Birmingham, AL. “The CRE Wireguided Balloon is easy to place and is consistent and reliable for inflation size and pressure. I am very comfortable with this balloon for the DASE application as I’ve been using it for many years for esophageal and gastric stenosis.”

“Large stone extraction with DASE is easy, procedures are completed faster, and I have achieved a high rate of complete stone clearance,” said Riad Azar, M.D., Barnes Jewish Hospital, St. Louis, MO. “The technique is easy to learn, and I have taught a number of referring physicians who are now doing it successfully.”

Company comments

“The CRE Wireguided Balloon Dilator for the DASE procedure provides a new and alternative endoscopic therapy for the more than 60 million people worldwide affected by the presence of stones in the common bile duct,” said David Pierce, president of the endoscopy division at Boston Scientific. “The CRE Wireguided Balloon Dilator is a core product in our endoscopy portfolio, and it underscores our ongoing commitment to advancing treatments that meet the needs of patients and physicians.”